RAMON R RODRIGUEZ

*** ******* ***. *******, **, *7011

973-***-****, e-mail: ac40uc@r.postjobfree.com

SUMMARY

Results and process oriented engineer who drives continuous improvements, quality control /assurance in pharmaceutical manufacturing and chemical environments. Knowledge in clean manufacturing, sterilization processes, environmental monitoring and process validation IQ/OQ/PQ, change control and tech transfer.

Experience in supervising, team- building, motivating and coaching production/manufacturing personnel.

Proficient in SOPs writing, translating analytical data into business results, capital equipment evaluation.

Experience in Internal audits, Safety audits, ICH, FDA and EMEA GMP directives, CAPA, OSHA/EPA.

EXPERIENCE

Laporte Consultants, Commack, NY

Position: Consultant (Process and Validation Engineer). Jan 2016 – Dec 2016

Function: Process engineering and start up validation at client’s site.

Write and execute IQ, OQ and PQ validation protocols for facilities and equipment.

Analyzed water, compressed air and surface monitoring sample results from the Test Laboratory and ensure that results obtained were within protocol specified limits, resolve deviations as needed.

Wyeth (now Pfizer), Pearl River, NY 2002-2015

Position: Process Scientist (Vaccines R&D) 2009-2015

Function: Fermentation Process Development and Scale up. Early Phase Development

Work in group for the fermentation process of new vaccines in the pipeline.

Conduct departmental safety audits through the group working labs.

Sterilized fermenter media at various autoclave time points and temperature.

Interact with other team members to identify improvements and optimization effects using DOE models.

Run assays and analyze the yields in accordance to specifications.

Assist in the development of different fermentation media and feeds for productivity.

Clean and set up fermenter vessel, ensure calibration and PM on critical equipment.

Prepare and autoclave media for fermentation following instruction sheet or formulation.

Ensure autoclave temperature distribution studies via Kaye probe validator.

Assist on the Tech Transfer and validation of processes to manufacturing groups.

Maintain good recording of experiment in lab notebooks and assist in technology transfer.

Vaccines Supervisor (3rd Shift)/Sr. Supervisor (Facilities and Environmental Monitoring) 2002 - 2009

Accountable for maintaining equipment and facilities and supervising personnel to sustain a high level in production operations of quality, timeliness, safety, efficiency, and compliance with current Good Manufacturing Practice regulations (cGMP), FDA regulations, Standard Operating Procedures (SOPs), product licenses, and corporate policies.

Supervised daily operations on the aseptic liquid vial filling line and automated vial inspection line, including checking that areas are clean and properly cleared, assigning hourly personnel to appropriate areas.

Assured that the CAPA, Preventive Maintenance issues were resolved in timely manner.

Assured all critical equipment was listed on Maximo and maintain material inventory.

Became SME in LIMS and ensured operators were trained for proper sampling handling and reporting.

Oversaw set-up workers monitoring building facility systems (i.e., Water For Injection) and HVAC systems (i.e., temperature, pressure differential, viable/nom-viable particle).

Review and approved filter integrity tests and autoclave efficiency cycle results.

Maintain validation and preventive maintenance spreadsheet current.

Wrote and revised departmental SOPs to keep them current.

Performed root cause analysis on a vial capping machine to improve efficiency.

Prepared and filed timely Manufacturing Investigation Reports (MIRs) as needed for production deviations. Initiated and followed-up on corrective actions and product complaints on a timely basis.

Reviewed and approved departmental IQ/OQ and PQ protocols.

Participated in re-validation of autoclave and lab washer and ensure all test passed to specified limits.

Executed sterile media simulations, cleaning validation and smoke test of the critical area.

Contributed and executed tasks for a department conversion to a Non-GMP facility.

Participated in the decision making during change control and product review program.

Approved time sheets for non-exempt employees in absence of Director/Assoc. Director.

Trended and analyzed environmental data to maintain compliance with departmental SOPs.

Applied root cause analysis (Fishbone diagram) to assist closing open investigation/deviations.

Ensure that specified amount of production samples were taken and sent to Lab for analysis.

In conjunction with QA and Compliance groups performed internal inspection to the GMP areas and assisted in corrective actions and closed investigations in TrackWise.

Inspected equipment suppliers and manufactures before commit buying equipment.

Followed good documentation practices through the batch runs, cleaning and environmental monitoring activities to reduce the incident of deviations.

Ensure that the fill/finish, inspection and packaging production batch record were completed in accordance to internal procedures and GMP practices.

Supervised the inspection and packaging line when required. Batch record closure.

Participated on the hiring and disciplinary process of Lab Assistant and union personnel

Train junior supervisors and lab assistants in cGMP practices, gowning and related SOPs.

BOC GASES, Murray Hill, NJ

Position: Product/Project Development Engineer 2001 – 2002

Function: Managed the development of small packaged cryogenic plants to meet capital and gas cost targets set by Business Development. Set schedules and target dates to meet plant design requirements.

Planned, directed and coordinated the development of standard documents; P&ID, PFD, electrical, structural, civil, instrumentation drawings and scope of supply and bill of materials to obtain a finished plant design. Perform HAZOP studies and Project Safety reviews for the designed plants.

EDUCATION

Stevens Institute of Technology, Hoboken, NJ Major: Grad. Certif. Pharma Manufacturing

Stevens Institute of Technology, Hoboken, NJ Major: Executive Master of Management

New Jersey Institute of Technology, Newark, NJ Major: B.S. Chemical Engineering/Math

TECHNICAL SKILLS

SPC, Lean Six Sigma, cGMP, HAZOPs, FMEA, Supply Chain, Process Validation. HPLC

C/C++, Ms-Office, MS-Project, TrackWise, SAP, LIMS, CAPA, Minitab, Change Control.

21 CFR 210/211, part 11, ICH and EU directives.

AWARDS

June 2015 – Certificate of Achievement. Lead Development Milestone

March 2015 – Trumenba Vaccine recognition award.

March 2015 – Prevnar 13 Vaccine, cash award

Dec. 2007 – Above and Beyond Award, for extended hours to get assay done on time

Nov. 2007 – Development track Achievement Award.

Feb. 2004 – Cash Award. Performance Incentive Award, Wyeth Pharmaceuticals.

VOLUNTEER

Boys Scouts of America Troop #1- Chaptered Organization Rep

PROFESSIONAL ASSOCIATIONS

American Society for Quality

American Institute of Chemical Engineers

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